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Use Lay Language. HA Score to Identify Myeloma Patients Who Could Benefit From HDACi Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515915
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Poitiers University Hospital
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.

A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).

Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.


Condition or disease
Patients With Recurrent or Refractory Multiple Myeloma

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value [ Time Frame: 1 day ]
    Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value


Secondary Outcome Measures :
  1. Progression free survival will be monitored. [ Time Frame: 1 day ]
    Progression free survival will be monitored.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Relapsed/refractory multiple myeloma
Criteria

Inclusion Criteria:

  • Relapsed/refractory multiple myeloma
  • Aged 18 years or more with no upper age limit
  • Have signed an informed consent

Exclusion Criteria:

NA


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515915


Contacts
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Contact: JEROME MOREAUX, PhD 467337903 ext 33 j-moreaux@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: JEROME MOREAUX, PhD    467337903 ext 33    j-moreaux@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Poitiers University Hospital
Investigators
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Study Director: JEROME MOREAUX, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03515915    
Other Study ID Numbers: UF9760
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
multiple myeloma
HDAC inhibitor
Biomarker
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action